Treating Caregiver Depression to Improve Childhood Asthma: Impact and Mediators

Asthma Clinical Trial

Official title: Treating Caregiver Depression to Improve Childhood Asthma: Impact and Mediators

Status Completed

Clinical Trial Summary

The investigators propose a one-year, repeated measures, within-subject design to examine the impact of improved caregiver depression on child asthma outcomes. A cross-lagged panel modeling (CLPM) for longitudinal data will be fit using a maximum likelihood structural equation model (SEM) in order to explore longitudinal mediation between asthma outcomes (asthma control, spirometry, quality of life (QOL)) and depressive symptoms. CLPM will test whether caregiver improvement preceded child asthma improvement, and SEM will test whether improved adherence and/or decreased child anxiety/depression mediated the effect. The investigators considered a randomized control trial, but it would not be ethically acceptable to withhold medication from caregivers diagnosed with Major Depressive Disorder (MDD) for the proposed one-year duration of the study. It is unlikely that potential participants in the study would find this acceptable. Furthermore a controlled design is not necessary since the investigators are not testing the efficacy of antidepressants for depression, but rather the impact of improvement on caregiver depression on the child.

Clinical Trial Description

Caregiver will be consented for his/her and the child's participation. The child will assent to participate before study procedures begin. The proposed study will last 52 weeks and consist of study visits every 4 weeks (14 visits total). Screening (roughly 5 mins): 2 item Self-Report Screening Tool for Depression (2-SRSD) This tool will be used to help screen caregivers for the study. This screening will only be performed in the clinic. Additional screening will be performed at the Baseline visit including: - Obtaining demographic information - Physical exam, - Medical and psychiatric history - Physical health assessments - Urine Pregnancy Test for women of childbearing potential - Mood assessments The baseline visit is described below: Baseline (approx 3 hrs): The following assessments will be given to the Caregiver only: 1. Structured Clinical Interview for DSM V (SCID) 2. Urine Pregnancy Test (UPT) for women of child bearing potential 3. Hamilton Rating Scale for Depression (HRSD) 4. Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR) 5. State Trait Anxiety Inventory (STAI) 6. Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQOL) 7. Psychobiology of Recovery in Depression III Somatic Symptom Scale (PRD-III) The following assessments will be given to the child: 1. Composite Asthma Severity Index (CASI) 2. Children's Depression Inventory (CDI) 3. Screen for Child Anxiety Related Disorders (SCARED) 4. Pediatric Asthma Quality of life Questionnaire (PAQOL) 5. Asthma Control Test/Childhood Asthma Control Test (ACT/cACT) (which version is given will be determined by the child's age) 6. Spirometry measurement 7. Perceived Stress Scale (PSS) 8. Relatedness Scale The following assessments will be given to both the caregiver AND the child: 1. Childhood Asthma Management Program Continuation Study Medication Adherence Interview (CAMPCS) Weeks 4-48 (visits every 4 weeks, each approx 2 hours): Caregiver only: HRSD, QIDS-SR, STAI, PACQOL, PRD-III, UPT Child only: CASI, CDI, SCARED, PAQOL, ACT/cACT, Spirometry, PSS, Relatedness Scale Both caregiver AND child: CAMPCS Week 52 (approx 2.5 hrs): Caregiver only: HRSD, QIDS-SR, STAI, PACQOL, PRD-III, UPT Child only: CASI, CDI, SCARED, PAQOL, ACT/cACT, Spirometry, PSS, Relatedness Scale Both caregiver AND child: CAMPCS, Debriefing interview Electrocardiograms (ECG) and blood tests may be collected during this study as is clinically indicated. ;

Related Conditions & MeSH terms

• Asthma
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

• NCT number: NCT02809677
• Study type: Interventional
• Source: University of Texas Southwestern Medical Center
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Completion date: October 2020